Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 29, 2017 Dipped Products (Thailand) Limited % Indraj Bamrah Senior Regulatory Consultant Emergo Group 816 Congress Avenue, Suite 1400 Austin. Texas 78701 Re: K161929 Trade/Device Name: Palm-Pro Nitrile Powder Free Examination Glove, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: February 8, 2017 Received: February 10, 2017 Received: February 19, Dear Indraj Bamrah: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. # Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K161929 Device Name Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs #### Indications for Use (Describe) The Palm-pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove has also been tested for use with Chemotherapy Drugs. The following Chemotherapy drugs have been tested for use with these gloves in accordance with ASTM D6978-05: | Chemotherapy drug (concentration) | Breakthrough Detection Time | |---------------------------------------|-----------------------------------| | Dacarbazine (10,000 ppm) | No breakthrough up to 240 minutes | | *Carmustine (BCNU) (3,300 ppm) | Breakthrough at 30.6 minutes | | Cyclophosphamide (20,000 ppm) | No breakthrough up to 240 minutes | | Doxorubicin Hydrochloride (2,000 ppm) | No breakthrough up to 240 minutes | | Fluorrouracil (5,000 ppm) | No breakthrough up to 240 minutes | | Cisplatin (1,000 ppm) | No breakthrough up to 240 minutes | | Etoposide (20,000 ppm) | No breakthrough up to 240 minutes | | Paclitaxel (6,000 ppm) | No breakthrough up to 240 minutes | | Thiotepa (10,000 ppm) | Breakthrough at 181.3 minutes | *Please note that the following drug has extremely low permeation times: Carmustine (BCNU): 30.6 minutes. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## Section 5 – 510(k) Summary ## Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs ## K161929 #### 1. Submission Sponsor Dipped Products (Thailand) Ltd 82/2 MOO 9, Tumbon Rattapum Amphur Khun Nieng Songkhla, 90220 Thailand Phone number: +66 74302100 Contact: Mr. Nilaksha Pushpakumara Title: Factory Manager #### 2. Submission Correspondent Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 Office Phone: (512) 327.9997 Contact: Indraj Bamrah, Senior Consultant, Regulatory Email: project.management@emergogroup.com #### 3. Date Prepared February 8, 2017 {4}------------------------------------------------ #### 4. Device Identification | Trade/Proprietary Name: | Palm-Pro Nitrile Powder Free Examination Glove, tested for use with<br>Chemotherapy drugs | |-------------------------|-------------------------------------------------------------------------------------------| | Common/Usual Name: | Patient Examination Glove | | Classification Name: | Patient Examination Glove | | Regulation Number: | 880.6250 | | Product Code: | LZA, Polymer Patient Examination Glove | | | LZC, Patient Examination Glove, Specialty | | Device Class: | Class I | | Classification Panel: | General Hospital | #### 5. Legally Marketed Predicate Device(s) K141982, Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs, WRP Asia Pacific Sdn Bhd. #### 6. Device Description The Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs are patient examination gloves that worn by an examiner to prevent contamination between the patient and examiner. The gloves are suitable for use with Chemotherapy drugs, are ambidextrous and green in color. The gloves are supplied non-sterile, in boxes of 100 (measured by weight), intended for single use and are disposable. #### 7. Indication for Use Statement The Palm-pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs is a nonsterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove has also been tested for use with Chemotherapy Drugs. The following Chemotherapy drugs have been tested for use with these gloves in accordance with ASTM D6978-05: | Chemotherapy drug (concentration) | Breakthrough Detection Time | |-----------------------------------|----------------------------------| | Dacarbazine (10,000 ppm) | No breakthrough up to 240 minute | | *Carmustine (BCNU) (3,300 ppm) | Breakthrough at 30.6 minutes | {5}------------------------------------------------ | Cyclophosphamide (20,000 ppm) | No breakthrough up to 240 minutes | |--------------------------------------|-----------------------------------| | Doxorubicin Hydrocloride (2,000 ppm) | No breakthrough up to 240 minutes | | Fluorrouracil (5,000 ppm) | No breakthrough up to 240 minutes | | Cisplatin (1,000 ppm) | No breakthrough up to 240 minutes | | Etoposide (20,000 ppm) | No breakthrough up to 240 minutes | | Paclitaxel (6,000 ppm) | No breakthrough up to 240 minutes | | Thiotepa (10,000 ppm) | Breakthrough at 181.3 minutes | *Please note that the following drug has extremely low permeation times: Carmustine (BCNU): 30.6 minutes. #### 8. Substantial Equivalence Discussion The following table compares the Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device. | | | Table 5A - Comparison of Characteristics | |--|--|------------------------------------------| |--|--|------------------------------------------| | Manufacturer | Dipped Products (Thailand) Ltd | WRP Asia Pacific Sdn Bhd | | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Palm-Pro Powder Free Nitrile<br>Examination Glove, tested for<br>use with Chemotherapy drugs | Dermagrip Powder Free Blue<br>Nitrile Patient Examination<br>Gloves, Non-Sterile, Tested for<br>use with Chemotherapy Drugs | Significant<br>Differences | | 510(k) Number | K161929 | K141982 | | | Product Code | LZC | LZC | Same | | | LZA | LZA | | | Regulation Number | 880.6250 | 880.6250 | Same | | Regulation Name | Patient Examination Glove | Patient Examination Glove | Same | | Indications for Use | The Palm-Pro Nitrile Powder<br>Free Examination Glove, tested<br>for use with Chemotherapy<br>drugs is a non-sterile disposable<br>device intended for medical<br>purposes that is worn on the | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or finger<br>to prevent contamination<br>between patient and examiner.<br>These gloves were tested for | Similar | | Manufacturer | Dipped Products (Thailand) Ltd | WRP Asia Pacific Sdn Bhd | Significant Differences | | Trade Name | Palm-Pro Powder Free Nitrile Examination Glove, tested for use with Chemotherapy drugs | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs | | | | examiner's hand to prevent contamination between patient and examiner. The glove has also been tested for use with Chemotherapy Drugs.<br>*Please note that the following drug has extremely low permeation times:<br>Carmustine (BCNU): 30.6 minutes. | use with Chemotherapy Drugs.<br>*Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 15 minutes and Thiotepa: 2 minutes. | | | Permeation times for Chemotherapy drugs | Breakthrough Detection time | | Similar. The subject device when tested with Carmustine and Thiotepa are found to have higher breakthrough times than the predicate device. detection times | | Chemotherapy Drug tested (concentration) | | | | | Dacarbazine (10,000 ppm) | No breakthrough up to 240 minutes | >240 minutes | | | Carmustine (BCNU) (3,300 ppm) | Breakthrough at 30.6 minutes | 15.0 minutes | | | Cyclophosphamide (20,000 ppm) | No breakthrough up to 240 minutes | >240 minutes | | | Doxorubicin Hydrochloride (2,000 ppm) | No breakthrough up to 240 minutes | >240 minutes | | | Fluorouracil (5,000 ppm) | No breakthrough up to 240 minutes | >240 minutes | | | Cisplatin (1,000 ppm) | No breakthrough up to 240 minutes | >240 minutes | | | Etoposide (20,000 ppm) | No breakthrough up to 240 minutes | >240 minutes | | | Paclitaxel (6,000 ppm) | No breakthrough up to 240 minutes | >240 minutes | | | Thiotepa | Breakthrough at 181.3 minutes | 2.0 minutes | | | Manufacturer | Dipped Products (Thailand) Ltd | WRP Asia Pacific Sdn Bhd | Significant<br>Differences | | Trade Name | Palm-Pro Powder Free Nitrile<br>Examination Glove, tested for<br>use with Chemotherapy drugs | Dermagrip Powder Free Blue<br>Nitrile Patient Examination<br>Gloves, Non-Sterile, Tested for<br>use with Chemotherapy Drugs | | | (10,000 ppm) | | | | | Material | Nitrile | Nitrile | Same | | Single Use | Yes | Yes | Same | | Dimensions | Overall length: 240mm min. | Overall length: 240mm min. | Same | | Thickness Specification | Finger: 0.09 – 0.10mm<br>Palm: 0.07 – 0.08mm | Finger: 0.07 – 0.10mm<br>Palm: 0.07 – 0.09mm | Similar. The<br>thickness<br>specification<br>of the<br>subject<br>device is<br>within the<br>bounds of<br>that of the<br>predicate<br>device. | | Physical Properties<br>(ASTM D6319-10) | Meets requirements | Meets requirements | Same | | Freedom from holes | Passes | Passes | Same | | Residue Powder Test | Passes | Passes | Same | | Color | Green | Blue | Similar. The<br>green color<br>does not<br>raise new<br>questions of<br>safety and<br>effectiveness. | | Biocompatibility | | | Same | | Skin Irritation<br>(ISO 10993 - 10) | Under the conditions of the<br>study, the device was non-<br>irritating | Not a primary skin irritant under<br>the conditions of the study | | | Dermal Sensitization (ISO<br>10993 - 10) | Under the conditions of the<br>study, the device was non-<br>sensitizing | Not a contact sensitizer under<br>the conditions of the study | | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### 9. Non-Clinical Performance Data As part of demonstrating that the Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs meets the required specifications and in showing substantial equivalence to the predicate device, Dipped Products (Thailand) Ltd. completed a number of non-clinical performance tests. The Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs meets all the requirements for overall design, performance and biocompatibility results confirming that the design output meets the design inputs and specifications for the device. The Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device: - . Biocompatibility testing per ISO 10993-10: tests for dermal sensitization and primary skin irritation: For primary skin irritation: Under the conditions of the device was non-irritating. For dermal sensitization: Under the conditions of the device was non-sensitizing. - . Dimension tests in accordance with ASTM D6319-10: tests for palm width, overall length, palm thickness and finger thickness: PASS - . Water leak test in accordance with ASTM D6319-10: determination of AQL level: PASS - . Tensile strength and ultimate elongation in accordance with ASTM D6319-10: testing conducted preaging and after aging: PASS - . Powder content in accordance with ASTM D6319-10: residual powder content determined per glove: PASS - . Permeation Testing for Chemotherapy Gloves in accordance with ASTM D 6978-05: Break through time tested and reported for nine drugs. #### 10. Statement of Substantial Equivalence The Palm-Pro Nitrile Powder Free Examination Glove, tested for use with Chemotherapy drugs, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device as it has the same intended use and similar technological characteristics as the previously cleared predicate device.